Omeprazole 20 mg in Patients With Laryngopharyngeal reflux and Comorbid Chronic Rhinosinusitis

Phase 4

Completed

• Conditions: Laryngopharyngeal Reflux; Chronic Rhinosinusitis (Diagnosis)
• Interventions: Drug: Omeprazole 20mg; Drug: Placebo oral capsule

• Registration Number: NCT03086070
• Lead Sponsor: Children's Hospital Srebrnjak

Brief Summary

The hypothesis of this study is that a gastroesophageal reflux recommended treatment with proton pump inhibitor (dose and duration) compared to placebo significantly reduces both the signs and symptoms of laryngopharyngeal reflux and comorbid chronic rhinosinusitis. Primary objective was to determine whether 8 weeks of treatment with omeprazole 20 mg ones daily (OD) significantly reduces the signs and symptoms of laryngopharyngeal reflux when compared to placebo in patients with laryngopharyngeal reflux with comorbid chronic rhinosinusitis. Secondary objectives were to determine whether 8 weeks of treatment with omeprazole 20 mg OD significantly reduces the signs and symptoms of comorbid chronic rhinosinusitis in patients with laryngopharyngeal reflux when compared to matching placebo; and to investigate the association of the severity of signs and symptoms of laryngopharyngeal reflux with the ones of chronic rhinosinusitis in the same group of patients. The research was carried out as a double blind randomized placebo controlled trial. Patients were randomized into two groups in an approximate 1:1 ratio using a concealed random sequence. After randomization and initial assessment treatment was initialized. Patients on active treatment were given omeprazole 20 mg once daily half an hour before breakfast for 8 weeks, while those in the placebo group were given matching placebo tablets using the same regimen for 8 weeks as the group on the active treatment. Patients were reassessed at the end of treatment for signs and symptoms of laryngopharyngeal reflux and comorbid chronic rhinosinusitis.

Detailed Description

Not available

Study Timeline

• Study Start: 2010-01-01
• Primary Completion: 2010-04-30
• Study Completion: 2010-06-30
• Study First Submitted: 2017-03-06
• Study First Submitted QC: 2017-03-15
• Study First Posted: 2017-03-22
• Status Verified: 2020-12
• Last Update Submitted: 2020-12-29
• Last Update Posted: 2020-12-30

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 60

Inclusion Criteria

• laryngopharyngeal reflux
• chronic rhinosinusitis

Exclusion Criteria

• allergic rhinitis
• asthma
• cystic fibrosis
• nasal polyposis
• severe systemic diseases

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Treatment arm	Omeprazole 20mg	omeprazole 20 mg capsule once daily for 8 weeks
Placebo arm	Placebo oral capsule	matching placebo capsules ones daily for 8 weeks

Primary Outcome Measures

Name	Time	Method
Reduction in signs and symptoms of laryngopharyngeal reflux	8 weeks	Reflux finding score (RFS)

Secondary Outcome Measures

Name	Time	Method
Association of the severity of signs and symptoms of laryngopharyngeal reflux with the ones of chronic rhinosinusitis	Baseline and after 8 weeks of treatment.
Reduction of signs and symptoms of comorbid chronic rhinosinusitis	8 weeks	Nasal obstruction, anterior/posterior nasal drip, headache, sneezing, cough, smell and taste disorder with frequency and intensity of the symptoms was graded from 0 (no problem) to 3 (severe problem).; Nasal endoscopy with endoscopy scores were based on the assessment of nasal mucosa edema, secretions and presence of polyps and were graded from 0 (no problem) to 3 (severe problem).